MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KERRISON; RONGUER

Catalog Number 57-0693

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The product has not yet been received for evaluation.There has been a total of (b)(4) sold of this part number with no additional complaints recorded for this occurrence.A follow up report will be submitted once the product is retrieved for evaluation.

Event Description

While performing an minimally invasive microlumbar discectomy, the lumbar kerrison tip broke off in the patient's incission while attempting to remove bone.The surgeon was able to retrieve the broken kerrison tip with no additional affect on the patient.

Manufacturer Narrative

Upon receiving the device, it was determined that the lot number was 20161746.Based on this lot number, it can be determined that it was purchased in (b)(6) 2019.This type of damage is consistent with biting something too large or hard for the device especially while dull.The material and hardness for the device were reviewed with all readings found to be within conformance per the product specifications and intended use.Based on the evaluation of the device the risk assessment, no further actions are required.This can be see as the final report.If additional information is obtained that allages any additional patient involvement or the need for corrective actions, a follow up report will be submitted.

• Brand Name: SYMMETRY KERRISON
• Type of Device: RONGUER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10652492
• MDR Text Key: 220756598
• Report Number: 3007208013-2020-00027
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482092613
• UDI-Public: 00887482092613
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 57-0693
• Device Lot Number: 20161746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention